MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILE TRAC SYSTEM STERILE TRAC 5 XD THINFLAP 1.5 X 4.0MM SCREW; PLATE, BONE

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical product: item 25-1005x, lot 068020; steriletrac system x-drive thinflap 2 hole straight plate.Report source: foreign: (b)(6).A visual inspection was conducted on the returned product per inspection criteria.The packaging was then opened to further investigate the total pieces of debris and a single hair could be seen inside the sterile pack.The complaint is confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause is attributed to a manufacturing issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00050.

Event Description

It was reported that non-conforming goods were discovered in the distributor's warehouse in (b)(6) 2021.Subsequently, the issue has been identified as foreign material in the package.

• Brand Name: STERILE TRAC SYSTEM STERILE TRAC 5 XD THINFLAP 1.5 X 4.0MM SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13509729
• MDR Text Key: 285651680
• Report Number: 0001032347-2022-00051
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888233019545
• UDI-Public: (01)00888233019545(17)251130(10)221500
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SP-ST5-6704
• Device Lot Number: 221500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1